A diverse pipeline of topical skin medications

EPSOLAY®

(benzoyl peroxide) Cream, 5%
Papulopustular Rosacea

PDUFA Goal April 26, 2021

TWYNEO®

(benzoyl peroxide and tretinoin)
Cream, 3%/0.1%
Acne Vulgaris

NDA Submission
October 2020

SGT-210

Palmoplantar Keratoderma

Results in
1H 2021

Currently in Phase 1

SGT-310

Psoriasis & Other Dermatological Indications

Formulation

SGT-510

Psoriasis & Other Dermatological Indications

Formulation

The safety and efficacy of these products have not been established.

Our Microencapsulation Technology

EPSOLAY

Epsolay is an investigational topical cream containing benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process that is designed to slowly release benzoyl peroxide over time to the skin. The FDA has accepted our NDA for Epsolay with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first single-active benzoyl peroxide approved by the FDA as a prescription drug product.

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The safety and efficacy of Epsolay have not been established.
Epsolay is a registered trademark of Sol-Gel Technologies, Ltd.

Not an actual patient – actor portrayal

Not an actual patient – actor portrayal

EPSOLAY

Epsolay is an investigational topical cream containing benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process that is designed to slowly release benzoyl peroxide over time to the skin. The FDA has accepted our NDA for Epsolay with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first single-active benzoyl peroxide approved by the FDA as a prescription drug product.

Learn More

The safety and efficacy of Epsolay have not been established. Epsolay is a registered trademark of Sol-Gel Technologies, Ltd.

Not an actual patient – actor portrayal

TWYNEO

Twyneo is an investigational, antibiotic-free, fixed-dose combination of benzoyl peroxide, 3%, and tretinoin, 0.1%, cream for the treatment of acne vulgaris, using our proprietary drug-delivery technology. If approved, it has the potential to be the first acne treatment on the market that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are each approved as single-agent products for the treatment of acne. They are frequently prescribed together, however, they have not yet been marketed as a combination product because benzoyl peroxide causes degradation of tretinoin when combined in the same formulation. In Twyneo, each ingredient is encapsulated in a silica shell, which is designed to release the ingredients slowly over time. Phase 3 studies are complete and we submitted our New Drug Application in October 2020.

Learn More

The safety and efficacy of Twyneo have not been established. Twyneo is a registered trademark of Sol-Gel Technologies, Ltd.

TWYNEO

Twyneo is an investigational, antibiotic-free, fixed-dose combination of benzoyl peroxide, 3%, and tretinoin, 0.1%, cream for the treatment of acne vulgaris, using our proprietary drug-delivery technology. If approved, it has the potential to be the first acne treatment on the market that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are each approved as single-agent products for the treatment of acne. They are frequently prescribed together, however, they have not yet been marketed as a combination product because benzoyl peroxide causes degradation of tretinoin when combined in the same formulation. In Twyneo, each ingredient is encapsulated in a silica shell, which is designed to release the ingredients slowly over time. Phase 3 studies are complete and we submitted our New Drug Application in October 2020.

Learn More

The safety and efficacy of Twyneo have not been established.
Twyneo is a registered trademark of Sol-Gel Technologies, Ltd.

Not an actual patient – actor portrayal

SGT-210

SGT-210 (erlotinib) is an investigational, topical epidermal growth factor receptor inhibitor in development for the treatment of palmoplantar keratoderma (PPK), a group of skin conditions characterized by thickening of the skin on the hands and soles of the feet, as well as basal cell carcinoma and squamous cell carcinoma, collectively referred to as non-melanoma skin cancer.

SGT-310 and SGT-510

We also intend to develop SGT-310 (tapinorof), an aryl hydrocarbon receptor (AhR) agonist, and SGT-510 (roflumilast), a phosphodiesterase 4 (PDE4) inhibitor, each as potential treatments for psoriasis and other dermatological indications.

The safety and efficacy of these products have not been established.